Magnesium Sulfate

Product NDC
0338-1719
11-digit product format
003381719
Labeler code
0338
Product ID
0338-1719_4607ad92-bf37-439d-92ec-51ee3cdf8318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate Heptahydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA211966
Marketing category
ANDA
Marketing start
2020-06-01
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
4 g/50mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Magnesium Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE4 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui829734, 1658259, 1658262, 2731632

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-1719-40Magnesium Sulfate40 in 1 CARTONINJECTION, SOLUTION4012
0338-1719-40Magnesium Sulfate50 mL in 1 BAGINJECTION, SOLUTION5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1719-40ML - Milliliter0338-171930c2b8b0-e23f-4f42-b8ee-6fd1137c281112021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1719MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]10Current NDC, Legacy NDC, 2 package rows20250425_ea05b8f9-6e11-45c3-824a-4a78818019df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658259magnesium sulfate 2 GM in 50 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
2731632magnesium sulfate 3 GM in 100 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
1658262magnesium sulfate 4 GM in 100 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
829734magnesium sulfate 4 GM in 50 ML InjectionPSNea05b8f9-6e11-45c3-824a-4a78818019df12
2731632100 ML magnesium sulfate 30 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
1658262100 ML magnesium sulfate 40 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
165825950 ML magnesium sulfate 40 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
82973450 ML magnesium sulfate 80 MG/ML InjectionSCDea05b8f9-6e11-45c3-824a-4a78818019df12
1658259magnesium sulfate 2 GM per 50 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12
2731632magnesium sulfate 3 GM per 100 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12
1658262magnesium sulfate 4 GM per 100 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12
829734magnesium sulfate 4 GM per 50 ML InjectionSYea05b8f9-6e11-45c3-824a-4a78818019df12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1719-400033817194040 BAG in 1 CARTON (0338-1719-40) / 50 mL in 1 BAG40 bag2020-06-010000-00-00NoNoCurrent